The Drug Controller General of India (DCGI) has already issued a regulation outlining the need for makers, importers, and sellers of drugs, to report adverse events. However, on November 11, to enhance overall supervision, India issued a new pharmacovigilance document to major... Read More
Recently, there is a new regulation that allows the Thai FDA to hasten the review of device registration dossiers. It has agreed to let device companies reference registration dossiers for new registrations of the same product with different brand names. In short, the Thai FDA is... Read More
Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
China is rapidly becoming a key driver in the development of precision oncology drugs, facilitated by its rising cancer incidence, proactive government policies, and an influx of biopharma investment. China accounted for nearly a quarter of all global cancer diagnoses, with about 5 million... Read More
As mentioned in our October newsletter, the Korean MFDS drug review time is significantly longer than in other global markets. To help solve this problem, the MFDS is planning a new program in January to increase its drug review fees from about... Read More
As mentioned in our newsletter throughout the last year, Japan is trying to reduce their drug lag – where many innovative Western drugs have still not been registered in Japan. On October 23, one new notification and one revised notification were promulgated. For the... Read More
The Singapore government has recently been advocating for a newly launched Cybersecurity Labelling Scheme for Medical Devices that will help raise the bar for protection of healthcare data against cyber threats. Launched on October 16, the scheme labels medical devices based on their cybersecurity provisions assessed... Read More
India’s Drugs Controller General of India (DCGI) has implemented new measures to reinforce the monitoring of medical device related adverse events. This initiative is part of the Materiovigilance Programme of India (MvPI), managed by the Indian Pharmacopoeia Commission (IPC), which is in charge of collecting and analyzing... Read More
On October 21, 2024, China’s NMPA rolled out a pilot plan that allows non-end-to-end and segmented production of biologics between different facilities. In the past, the NMPA insisted the entire production process be done inside a single facility. This pilot plan is... Read More
As mentioned recently in our newsletter, Hong Kong’s Health Authority is being bulked up to take more responsibility in approving healthcare products. This past summer, the Department of Health set up the Hong Kong Centre for Medical Products Regulation. Whereas in the... Read More